There are about 9745 clinical studies being (or have been) conducted in Israel. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
Abstract: Background: The current "gold standard" epidural analgesia involves some undesirable side effects such as motor and sympathetic blockade. Here, the investigators suggest a new approach for inducing prolonged differential pain blockade during labor by selectively targeting local anesthetic chloroprocaine to the pain-related peripheral (nociceptive) fibers. The investigators approach involves nociceptor-selective anesthesia by selective targeting of ionized local anesthetics into nociceptive fibers via activation of nociceptor-specific TRPV1 channels. The authors demonstrated that activation of these channels by specific TRPV1-agonists (capsaicin or the local anesthetic lidocaine), allows entry of a polarized, membrane-impermeable lidocaine derivative (QX-314) specifically into nociceptive neurons, inhibiting their activity and pain blockade, without causing other neural effects. Capsaicin and QX-314 are not suitable for clinical use, as capsaicin causes severe injection pain and QX-314 is neurotoxic. Here, the investigators use lidocaine as the TRPV1 agonist, and use the high pKa chloroprocaine as the ionized local anesthetic instead of the toxic QX-314. Both drugs are in routine clinical use, but have not been described in co-administration before. The investigators preclinical results show that co-administration of chloroprocaine with TRPV1 agonists, leads to prolonged nociceptor-specific analgesia. KKK Hypothesis: The investigators hypothesize that co-administration of epidural lidocaine (to activate TRPV1 channels) and chloroprocaine (as a polarized local anesthetic which can gain preferential access to nociceptors via opened TRPV1 pores) will elicit selective nociceptive-anesthesia. Methodology: This study assess epidural local analgesia in nulliparous labor. There are 2 stages: Stage 1: Prior to direct comparison of lidocaine (Group L), chloroprocaine (Group C), and a lidocaine-chloroprocaine combination (Group L-C), the investigators first determine equipotential doses of epidural chloroprocaine and lidocaine using double-blinded up-down sequential analysis using the well-established minimum local anesthetic concentration (MLAC or ED50) design. ED50 is estimated using Dixon-Massey analysis and Wilcoxon and Litchfield probit regression. Stage 2: The main phase of the study involves a randomized double-blinded comparison between Groups L, C and L-C where all drug concentrations are based on the ED50/MLAC from the Stage 1. The primary endpoint is a composite measure of selective nociceptive analgesia (VAS pain score / modified Bromage motor score). Secondary outcomes are: 1. pain (VAS 0-100), 2. modified Bromage motor score, 3. thermal imaging of feet and hands, 4. sensory assessment to cold sensation using ice, 5. anesthesia requirement from the PCEA pump, 6. maternal blood pressure. 7. ambulation, and pushing ability in labor. Primary endpoint is assessed using repeated measures ANOVA (first 30-min) and mixed models ANOVA until first analgesic request. Implications: Positive findings will be the first evidence in humans of nociceptor-specific local anesthesia; will provide a more effective neuraxial analgesia protocol for labor, and will lead to future studies of systemic nociceptor-specific local anesthesia.
The goal of this retrospective study is to assess whether a selection of genetic variants may allow us to identify individuals who will have a satisfactory response after GLP-1 treatment in terms of weight loss, sugar level reduction, and adverse events. Participants will The study consists of a single visit at the diabetes unit clinic at the involved study sites. The following will be performed for every subject at the study screening enrollment visit: - Informed consent - Study eligibility (Inclusion / Exclusion criteria) - Collection of demographic data (age (date of birth), gender, ethnic origin) - General and T2DM medical history review (per subject file) - Concomitant medication review (at enrollment) - Physical attributes (Body Weight, Height, BMI) - Allocation to study cohort and study subgroup - Saliva and blood collection for genetic tests - Self-reported questionnaire for Ozempic (Semaglutide) experience
This is a two-part (Phase 2/Phase 3) study of V940, an individualized neoantigen therapy (INT), plus pembrolizumab in participants with locally resectable advanced cutaneous squamous cell carcinoma (LA cSCC). Phase 2 has three arms V940 plus pembrolizumab given as neoadjuvant and adjuvant treatment with standard of care (SOC), standard of care (surgical resection with/without adjuvant radiation therapy (RT) only at investigator's discretion) and pembrolizumab monotherapy given as neoadjuvant and adjuvant treatment with SOC. This phase will assess the safety and efficacy of V940 in combination with pembrolizumab as neoadjuvant and adjuvant therapy in participants with resectable LA cSCC as compared to standard of care SOC only. The primary hypothesis is that V940 plus pembrolizumab with SOC is superior to SOC only with respect to event free survival (EFS) as assessed by the investigator. Phase 3 expansion will be determined by prespecified Go-No-Go decision in which 412 additional participants will be randomized to V940 plus pembrolizumab with SOC and SOC only, without changing the inclusion/exclusion criteria for the additional enrollment or study endpoints.
this study will investigate the structure of the Achilles tendon and functional tests in road runners compared to treadmill runners.
The purpose of this study is to evaluate the efficacy of lepodisiran in reducing cardiovascular risk in participants with high lipoprotein(a) who have cardiovascular disease or are at risk of a heart attack or stroke. The study drug will be administered subcutaneously (SC) (under the skin).
The primary objective of this study to evaluate the efficacy of ravulizumab compared with placebo to reduce proteinuria and slow the rate of eGFR decline in adult participants with IgAN who are at risk of disease progression.
Primary objective: Phase I Proof of concept: treatment with smaller doses of elemental calcium from ACC compared to CCS can maintain target serum calcium (corrected for albumin) values (7.0-10.0 mg/dL). Phase II To test the hypothesis that treatment with smaller doses of elemental calcium from ACC compared to CCS can maintain target serum calcium (corrected for albumin) values (7.0-10.0 mg/dL). Secondary objectives: Phase I - ACC dose selection - to confirm the conversion factor of ACC from CCS - To determine the effect of food on ACC absorption Phase II - To test the hypothesis that treatment with smaller doses of elemental calcium from ACC compared to CCS will not cause an increase in hypercalciuria in patients with hypoparathyroidism - To test the hypothesis that smaller doses of elemental calcium from ACC can reduce the side effects related with high calcium consumption. Amorphical has a strong basis to believe that the ACC product is better absorbed compared to the commercially available CCS products and therefore, can maintain desirable target albumin corrected calcium values in serum (CA) with smaller doses of elemental calcium from ACC. As results, the burden of taking high doses of calcium supplementation along with the side effects of the standard therapy (gastrointestinal discomfort and hypercalciuria) will be reduced. Testing serum CA and urine calcium values in subjects with hypoparathyroidism may provide a straightforward method to test this hypothesis. The study is designed to be conducted with extra precaution in order to avoid disturbing the fragile balance between CA levels in serum and calcium levels urine. The crossover design of phase II of the study allows a more accurate and reliable comparison of results attributable to the specific treatment within the same individual. In addition, the subjects will continue consuming all their routine medication throughout the trial. The subjects in the control arm will consume their routine calcium supplement doses thus, will be treated with a standard of care.
The objective of this study is to assess the long-term efficacy of "AGE among on deep periodontal pockets by different doses of "AGE" for a period of 18 months.
The purpose of this study is to describe the use of teclistamab/talquetamab in the treatment of patients with RRMM outside of clinical trials.
Evidence shows that anti-fat attitudes and weight stigma are prevalent among healthcare professionals and may affect treatment decisions regarding patients with obesity. The present study aimed to examine the presence of anti-fat attitudes and weight stigma among orthopedic surgeons and their correlation to the therapeutic approach to patients with obesity. In this cross-sectional survey, 150 orthopedic surgeons will complete a web-based questionnaire. the questionnaire is based on Antifat Attitudes Questionnaire (AFA), developed by Crandall in 1994. In addition, the questionnaire will include a questionnaire developed by Bocquier in 200521 to explore weight stigma among physicians.